Career investigation report

Pharmacovigilance:

Overview:

Pharmacovigilance (PV) is also known as drug safety. It is the science of monitoring the
adverse events associated with the drug. It is the activity relating to collection, detection,
assessment, monitoring, and prevention of adverse effects with pharmaceutical products.
Before a drug is approved for marketing, it has to undergo clinical trials, where the patients
are selected carefully and monitored closely under controlled conditions. It means that the
drug has been tested in a relatively small number of patients. So the evidence of drug’s
safety and efficacy is limited to the results obtained from clinical trials.

After gaining marketing authorization, the drug is consumed by large number of patients for
prolong period of time and in combination with other drugs. So the chances of patients
experiencing adverse effects in such circumstances are relatively high. Hence, it is necessary
to monitor the safety of a medicinal product throughout its use in healthcare practice. It is
the responsibility of a person known as Drug Safety Associate/ PV officer to manage the
reporting of adverse drug reactions/events and contribute towards human safety.

Job Description:

PV officer plays an important role in the development and testing of new medicines in the
pharmaceutical industry to ensure that the drugs available on the market are safe for
human use. PV officers/ Drug Safety Officers are responsible for monitoring of adverse
effects/side effects and also reporting the effectiveness of the medicinal products on the
market in the general population, in the clinical trials and hospitals. They provide support
for various PV operations. They are largely responsible for coordinating and management of
review and analysis of aggregate safety data. They work together closely with medical and
drug company representatives, doctors, patients and other healthcare professionals. A Drug
Safety Specialist is involved in drug safety monitoring activities such as conducting clinical
trials, keeping check on SOPs (Standard Operating Procedures), keeping check on the
regulations, medical supervision and conducting regular PV developments.

Evaluation of the profession:

Pharmacovigilance is the link between medical research, regulatory affairs and marketing.
The primary objective of any pharmaceutical company is to minimize adverse events/side
effects of a drug, to reduce improper use of medicinal products resulting in the need of risk
management. Therefore, it is necessary to identify, assess and prevent risks associated with
pharmaceutical products. The role of Pharmacovigilance is extremely important in an
environment ever more sensitive to the concept of risk–benefit ratio and transparency of
communications. There is an impact of increased company communications on the work
performed by PV specialists as they are involved in drafting the documents, summaries and
articles dealing with drug safety.
Role and Responsibilities of Pharmacovigilance Specialist:

Main responsibilities of a Drug Safety Officer include:

1) Management of Adverse Events

 To ensure that the cases meet validity criteria and also to evaluate the cases
carefully and accurately for consistency.
 To document and database the case according to the SOPs.
 To ensure that all reports (clinical development and post-marketing) received or
collected are triaged, assessed and entered in the Data Base.
 To code the adverse events, product safety information and product quality
complaints accurately.
 To validate reports before regulatory submission and perform final check of
CIOMS and/or MedWatch (if applicable)
 To assess the cases appropriately for case severity to prioritize the cases for
follow up.
 To review the data against source documents and submit the data as per the
regulatory timelines.
 To review and document the regulatory requests accurately and prepare
responses as per the requests.
 To files case reports according to appropriate archiving practices.

2) Involved in Clinical Study Activities

 To play an active role in reviewing contracts with investigators.

 To submit PV data in a timely manner.
 To verify the risks and adverse events listed in the IB (Investigator’s Brochure).
 To assess the seriousness of the reported cases accurately and maintain strict
follow up of treated cases.
 To compare information from pharmacovigilance database to clinical research
database.
 To follow up for clarification or missing information related to case reports, if
required.

3) Contribute to ensure compliance of pharmacovigilance activities

 To conduct case reconciliation with concerned department.

 To participate in the audits and inspections.
 To provide training to concerned person depending on training plan and manage
the training documents effectively.
 To verify the data according to information sources prior to undertaking case
reconciliation.
 To archive documents according to prevailing standards.
Skills required for Pharmacovigilance Specialist:

The employers seek candidates who possess following skills:

 Sense of responsibility
 Analytical and Synthesis skills
 Ability to work on multiple projects simultaneously
 Ability to work as part of a team
 Ability to keep tight deadlines and work under pressure
 Ability to inspire confidence and mutual respect
 Excellent communication skills with different internal and external stakeholders
 Fluency in English and French (spoken and written)
 Scientific expertise
 Versatility
 Meticulousness and attention to detail
 Planning skills and organized work habits
 Ability to use simple language based on target audience

Eligibility Criteria:

Pharmacovigilance is an excellent employment option for pharmacy, medical and life

science graduates.

 Pharmacovigilance Specialists should have University degree in health sciences

(bachelor’s, master’s or doctorate), pharmacy, nursing, medicine, or a related
discipline.
 Two to five years of relevant experience in pharmacovigilance, clinical research, or
regulatory affairs.

Employment Options:

 Depending on interest, experience and training, Pharmacovigilance Specialists can

become Senior Specialist, Project Leader, Manager, Director, Consultant, Trainer or
Educator.

People trained in Pharmacovigilance can find excellent employment options in the following
organizations:

 Pharmaceutical Companies
 Contract Research Organizations (CROs)
 Biotech companies.
 Knowledge Process Outsourcing (KPOs)
 Regulatory Authorities
Career development/scope in pharmacovigilance

Most of the pharmacovigilance professionals start their career in a case processing role, as a
drug safety associate or pharmacovigilance officer. Case processing mainly involves entering
patient information and reported side-effects of pharmaceutical products into a database.
This data is then evaluated by risk management teams. This is the point from where career
growth in PV takes one of two possible paths:

1. The line management path: It includes successive levels such as senior drug safety
officer, manager and director.

2. The technical path: It involves technical areas such as signal detection, risk
management and epidemiology roles such as senior pharmacovigilance scientists,
risk management specialists and senior vigilance managers.

This is difficult because of high competition for senior positions and fewer opportunities
available to gain exposure to the skills required for technical roles. Some technical areas like
signal detection require people with a much higher degree of scientific knowledge than case
processing roles. Technical knowledge is required to identify and discover the underlying
reasons for adverse events experienced by the patients. Candidates can gain these skills
through training and experience.

Barriers to Career Progression:

It is quite challenging to make a transition from case processing into signal detection and
risk management which are senior technical roles. Usually candidates with previous
experience in a similar role are preferred for such senior technical roles, however many
jobseekers who have several years of experience in case processing do not qualify for senior
technical drug safety roles.

One of the main obstacles in career progression in PV is most of the large pharmaceutical
companies have their case processing teams on different sites in different countries. The
people working in the isolated departments gain very little as the senior detection and risk
management staff is mostly based at the company’s global headquarters.